Proposta de implementação de rotinas padronizadas para biorrepositórios no complexo hospitalar da Universidade Federal do Ceará.

Abstract

Nowadays it is necessary for the evolution of clinical research, the collection and manipulation of biological samples for future clinical diagnoses and effective dosage of the drug before its commercialization, which does not cause harm to human beings. During the execution of a clinical research project, biorepositories can be generated; they provide new information to the researcher. The stability and traceability of the stored samples are crucial for the success of the immunobiological, biochemical, and molecular methods and the reliability of the results. Studies in this line of research aimed at standardizing daily routines can contribute to the quality of the samples. In this context, this research aims to answer the following question: What elements are necessary for the standardization and management of biological samples in the light of current legislation? This research aims to present a proposal for the implementation of standardized routines for biorepositories in the Hospital Complex of the Federal University of Ceará and is supported by the ideas of a case study, of a descriptive, documentary nature, with a qualitative and quantitative approach. The first phase of the research focused on the collection of secondary data using information stored in the Clinical Research Unit (UPC) and the characterization of the stored biological samples. The second phase included data collection, through structured observation of the actions performed by professionals who work directly with the handling and custody of biorepositories and the third phase was the application of a structured interview to employees who work directly with biorepositories. The data collection instrument was a questionnaire. Based on the results obtained in the phases described above, three proposals were suggested to improve the care and storage of biorepositories: Standard Operating Procedure (SOP) specific to the sector, flowcharts and operational technical manual. We hope that the results can contribute to increasing the quality of the biorepositories stored in the referred unit, as well as supporting new research on the subject.